DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on December 15, 2025, has been received and entered.
Claim Disposition
3. Claims 1-90, 105, 107, 111, 129, 131, 135 and 143-145 have been cancelled. Claims 91-104, 106, 108-110, 112-128, 130, 132-134, 136-142 and 146-158 are pending. Claims 91-104, 106, 109, 112-128, 130, 133, 136-142, 146-149 and 158 are under examination. Claims 108, 110, 132, 134 and 150-157 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. The claims are only being examined to the extent that they pertain to the elected subject matter.
Claim Objections
4. Claims 91-104, 106, 109, 112-128, 130, 133, 136-142, 146-149 and 158 are objected to because of the following informalities:
Claims 91-104, 106, 109, 112-128, 130, 133, 136-142, 146-149 and 158 are objected to because acronyms are not spelled out in the first occurrence (i.e, Fuc, GDP).
For clarity, precision of claim language and consistency it is suggested that claims recite “an” or ‘the’ appropriately pertaining to the full length and fragment language in claims 91, 103, 114, 127-130 and 133 (i.e, ‘an amino acid selected from the group consisting of’).
For clarity and consistency it is suggested that claims 91(iii), 93, 95, 97, 99, 114, 116, 118, 120-121, 123, 137,142, and 147 are amended to place a comma before the ‘wherein’ clause and to place the transitional phrase ‘and’ between the last two ‘wherein’ clause (i.e., “…a fucosyltransferase, wherein…. under conditions, and wherein the fucosyltransferase catalyzes….” See claim 91).
For clarity and precision of claim language it is suggested that claims 101 and 102 are amended to delete “being” and instead insert “is” (i.e. “…compound is selected…”).
For clarity and consistency it is suggested that claim 158 is amended to delete “according to” and instead recite “of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 91-104, 106, 109, 112-128, 130, 133, 136-142, 146-149 and 158 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. Claims 91-104, 106, 109, 112-128, 130, 133, 136-142, 146-149 and 158 are directed in part to a method for the production of a genus of fucosylated compounds, including Gal-beta1-[Fuc-alpha1,4]-GlcNAc, wherein said method requires contacting GDP-fucose and a carbohydrate substrate that comprises lacto-N-biose (LNB) including Gal-beta1,3-GlcNAc optionally linked to any lipid and in the presence of a genus of fucosyltransferases that comprise (i) full length structures or fragments (see claim 91 for example). The invention encompasses a genus of fucosylated compounds that can be produced by a cell modified by any means to produce GDP-fucose and/or LNB, and wherein the fucosyltransferases can have α-1,4-fucosyltransferase activity (see claim 114 for example). In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
There is a significant amount of structural variability with respect to the members of the genus of fucosyltransferases required by the claimed method. While the specification in the instant application discloses the structure of a limited number of species of the recited genus of fucosyltransferases which are able to fucosylate LNB, it provides no clue as to the structural elements required in any fucosyltransferase that can fucosylate LNB, or the structural elements required in any α-1,4-fucosyltransferase that can fucosylate LNB and in any cell with any metabolic modifications with any lipid linkages.
The claimed invention as amended is directed to “a method of producing a fucosylated compound (see claim 91 in its entirety) and a cell metabolically engineered for producing a fucosylated compound (see claim 114 in its entirety) and the claimed invention encompasses a large variable genus of structures and cells. Regarding the method set forth in claim 91 and the dependent claims hereto as well as the cell in claim 114, they encompass a compound that comprises a LNB that could be linked to any lipid; any structure that is 90% identical to SEQ ID NOs: 17, 4, 13, 14 and 23 the same is true of the cell (see claim 114) that is engineered with no description of how it is modified. Thus no correlation is made between structure and function as the structure is not clearly defined or the mechanism involving the cell. The claimed invention is directed to a large variable genus of lipids and cells. The claims are not commensurate in scope with the disclosure in the specification.
The claimed invention is overly broad and encompasses a large variable genus of structures with the recitation of percent language. The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus maybe satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 112, first paragraph remains and have been modified to reflect changes made to the claims.
Regarding the rejection under 112, first paragraph, applicant traverses the rejection stating that amendments were made to the claims such as the higher percentages. The rejection of record remains although some clarity improved in the claim language, not enough is provided. Not all issues raised were addressed in the amendment such as the genus of the cells, lipids, in combination with multiple sequence fragments continue to leave the claimed invention overly broad and not demonstrating possession of the entire genus, for example, there are no indicia as to how the cell is engineered or what cell type. The limitations of the specification cannot be read into the claims. Note also the objections which also speak to the lack of clarity in the claim language. Applicant’s argument is not deemed persuasive, thus the rejection remains.
The claimed invention does not for example recite, A method of producing a fucosylated compound, comprising: culturing an Escherichia coli or Saccharomyces Cerevisiae cell that has been genetically engineered to constitutively express a fuscoslytransferase with alpha-1,4-fucosyltransferase activity on the GlcNAc residue of LNB and/or Gal-B1,3-GlcNAc of a saccharide substrate…”.
Conclusion
7. No claims are presently allowable.
8. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652